Safety and Toxicity Study of Sorafenib in Patients With Kidney Cancer

Trial ID or NCT#

NCT00854620

Status

not recruiting iconNOT RECRUITING

Purpose

Determine time-to-progression (TTP) for an escalating dose schedule for subjects with progressive metastatic renal cell carcinoma treated with sorafenib

Official Title

A Phase 2 Study of Sorafenib in Patients With Metastatic Renal Cell Carcinoma at Stanford University

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: MALE
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. 1. Histologically- or cytologically-confirmed metastatic or unresectable renal cell carcinoma (RCC).2. must have a component of conventional clear cell renal carcinoma.3. No more than one prior systemic therapy.4. No prior vascular endothelial growth factor receptor agents.5. Prior palliative radiotherapy in metastatic lesion(s) is permitted, provided the subject has at least one measurable and/or evaluable lesion(s) that has not been irradiated.6. All major surgery of any type and/or radiotherapy must be completed at least 4 weeks prior to Day 1 dosing. Patients must have recovered from surgery and/or radiotherapy toxicity prior to Day 1 dosing.7. Measureable disease by RECIST criteria8. Karnofsky performance status at least 70% or ECOG not more than 29. Ability to give written informed consent10. At least 18 years old11. Negative pregnancy test within 7 days of Day 1 dosing (female subjects of childbearing potential)12. Sexually active fertile subjects must agree to use an accepted method of contraception during the course of the study for 3 months thereafter.13. ANC at least 1,500/uL14. Platelet count at least 100,000/uL15. AST/ALT not more than 2.5 times the upper limit of normal (ULN)16. Alkaline phosphatase not more than 2.5 x ULN17. Serum bilirubin not more than 1.5 x ULN18. Amylase/Lipase within normal range19. Urinalysis not more than 1+ protein20. Serum creatinine not more than 1.5 x ULN21. No active ischemia by ECG22. Echocardiogram or MUGA ejection fraction at least 40%
Exclusion Criteria:
  1. 1. Ongoing hemoptysis2. Cerebrovascular accident within 12 months3. Peripheral vascular disease with claudication on less than 1 block4. History of clinically significant bleeding5. Malignancy with true papillary/sarcomatoid features without any clear cell component6. Chromophobe7. Oncocytoma8. Collecting duct tumors9. Transitional cell carcinoma10. Deep venous thrombosis or pulmonary embolus within one year of consent11. Ongoing need for full-dose oral or parenteral anticoagulation. Low dose coumadin (1 mg) for maintenance of catheter patency or daily prophylactic aspirin is allowed12. Subjects with evidence of current central nervous system (CNS) metastases13. MRI or CT scan of the brain (with contrast, if possible) within 28 days prior to Day 1 dosing14. Significant cardiovascular disease defined as congestive heart failure (New York Heart Association Class II, II or IV)15. Angina pectoris requiring nitrate therapy16. Myocardial infarction within the last 6 months17. Uncontrolled hypertension (defined as blood pressure at least 160 mmHg systolic or at least 90 mmHg diastolic on medication)18. Ongoing requirement for systemic corticosteroid therapy (except replacement therapy for adrenal insufficiency). Topical and/or inhaled steroids are allowed.19. Uncontrolled psychiatric disorder20. Delayed healing of wounds, ulcers, and/or bone fractures21. Prior malignancy (EXCEPTIONS: adequately-treated basal cell or squamous cell skin cancer or any other cancer for which chemotherapy has been completed \> 5 years ago and from which the patient has been disease-free for \> 5 years)22. Pregnant23. Currently lactating24. Currently using St John's Wort (an herb)
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Investigator(s)

Sandy Srinivas
Sandy Srinivas
Medical oncologist, Urologic specialist, Genitourinary specialist
Professor of Medicine (Oncology) and, by courtesy, of Urology

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Contact

Haas Denise
6507361252

View on ClinicalTrials.gov